Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Fixed-Dose Combination of Perindopril/Amlodipine (Amlessa®) and Fixed-Dose Combination of Perindopril/Indapamide /Amlodipine (Co-Amlessa®) - Contribution to Management in newly diagnosed and uncontrolled hypertensive patients (PRECIOUS study)

    Summary
    EudraCT number
    		 2017-001596-23
    Trial protocol
    		 PL   SI   HR  
    Global end of trial date
    27 Sep 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Mar 2022
    First version publication date
    01 Nov 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    After the completion of the study and after the finalization of Clinical Study Report a noncompliance was discovered on one of the study sites. Ten patients were removed from the statistical analysis. Based on the new statistical analysis the Clinical Study Report V2.0 was prepared.
    Summary report(s)
    		 PRECIOUS_SYNOPSIS_V2.0-15022022

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KCT06/2017-PRECIOUS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03738761
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Krka, d.d., Novo mesto
    Sponsor organisation address
    Dunajska cesta 65, Ljubljana, Slovenia, 1000
    Public contact
    Tanja Kohek, Krka, d.d., Novo mesto Dunajska cesta 65 1000 Ljubljana, +386 14751236, tanja.kohek@krka.biz
    Scientific contact
    Tanja Kohek, Krka, d.d., Novo mesto Dunajska cesta 65 1000 Ljubljana, +386 14751236, tanja.kohek@krka.biz
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to establish the efficacy and safety of fixed-dose combination (FDC) of perindopril/amlodipine (Amlessa®) and fixed-dose combination of perindopril/indapamide/amlodipine (Co-Amlessa®) in wide populations of uncontrolled patients with arterial hypertension (AH) with special focus on effective continuous 24-hour blood pressure (BP) control. The purpose is also to establish the correlation between 24-hour central and peripheral BP.
    Protection of trial subjects
    Patients had 3 main follow-up visits (visit 2, visit 3 and visit 4) and final visit (visit 5) at the end of the study. At each of the three follow-up visits, patient`s office blood pressure (BP) was measured. If normal office blood pressure (NBP - defined as SBP < 140 mmHg and DBP < 90 (85 for patients with type 2 diabetes mellitus) mmHg) was achieved, the patient continued treatment with the study medication prescribed. If NBP was not achieved, study medication dose was increased in order to achieve NBP and to protect the patient. At visit 1 and visit 5, complete laboratory analysis (blood counts, clinical chemistry, liver enzymes, lipid measurements) was performed. To further protect the patients, on visits 2, 3 and 4 safety assessing laboratory analysis was performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Armenia: 112
    Country: Number of subjects enrolled
    Serbia: 84
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Poland: 103
    Country: Number of subjects enrolled
    Slovenia: 33
    Country: Number of subjects enrolled
    Croatia: 39
    Country: Number of subjects enrolled
    Hungary: 50
    Worldwide total number of subjects
    461
    EEA total number of subjects
    225
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    362
    From 65 to 84 years
    98
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 572 patients were screened from Croatia, Hungary, Poland, Slovenia, Armenia, Serbia and Russia. 461 patients were included in SAS (Safety Analysis Set) population, for which safety analyses were performed. 440 patients were included in FAS (Full Analysis Set) population, for which efficacy analyses were performed.

    Pre-assignment
    Screening details
    		 In general, eligible patients for the screening procedure were adult patients aged 18 years and above, of both genders, with arterial hypertension (naïve or on previous antihypertensive treatment), who currently do not participate in another clinical trial and who signed Informed Consent Form (ICF).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amlessa Arm
    Arm description
    		 In Amlessa arm were allocated antihypertensive medication naïve patients, patients on previous antihypertensive monotherapy and patients on previous dual antihypertensive therapy (based on the decision of the Investigator). Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amlessa 4 mg/5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Amlessa 4 mg/5 mg contains 4 mg perindopril tert-butylamine and 5 mg amlodipine (as amlodipine besilate).

    Investigational medicinal product name
    Amlessa 8 mg/5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Amlessa 8 mg/5 mg contains 8 mg perindopril tert-butylamine and 5 mg amlodipine (as amlodipine besilate).

    Investigational medicinal product name
    Amlessa 8 mg/10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Amlessa 8 mg/10 mg contains 8 mg perindopril tert-butylamine and 10 mg amlodipine (as amlodipine besilate).

    Arm title
    		 Co-Amlessa Arm
    Arm description
    		 In Co-Amlessa arm were allocated patients on previous dual antihypertensive therapy (based on the decision of the Investigator) and patients on previous triple antihypertensive therapy. Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Co-Amlessa 4 mg/5 mg/1.25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Co-Amlessa 4 mg/5 mg/1.25 mg contains 4 mg perindopril tert-butylamine, 5 mg amlodipine (as amlodipine besylate) and 1.25 mg indapamide.

    Investigational medicinal product name
    Co-Amlessa 8 mg/5 mg/2.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Co-Amlessa 8 mg/5 mg/2.5 mg contains 8 mg perindopril tert-butylamine, 5 mg amlodipine (as amlodipine besylate) and 2.5 mg indapamide.

    Investigational medicinal product name
    Co-Amlessa 8 mg/10 mg/2.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each tablet of Co-Amlessa 8 mg/10 mg/2.5 mg contains 8 mg perindopril tert-butylamine, 10 mg amlodipine (as amlodipine besylate) and 2.5 mg indapamide.

    Number of subjects in period 1
    		Amlessa Arm Co-Amlessa Arm
    Started
    265
    196
    Completed
    230
    182
    Not completed
    35
    14
         Consent withdrawn by subject
    10
    -
         Adverse event, non-fatal
    11
    4
         Other
    2
    -
         Lost to follow-up
    2
    -
         Incorrectly allocated to treatment
    8
    5
         Noncompliance
    1
    -
         Lack of efficacy
    1
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Amlessa Arm
    Reporting group description
    		 In Amlessa arm were allocated antihypertensive medication naïve patients, patients on previous antihypertensive monotherapy and patients on previous dual antihypertensive therapy (based on the decision of the Investigator). Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Reporting group title
    Co-Amlessa Arm
    Reporting group description
    		 In Co-Amlessa arm were allocated patients on previous dual antihypertensive therapy (based on the decision of the Investigator) and patients on previous triple antihypertensive therapy. Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Reporting group values
    		 Amlessa Arm Co-Amlessa Arm Total
    Number of subjects
    		 265 196 461
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.6 ( 12.1 ) 56.4 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 100 70 170
        Male
    		 165 126 291

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Amlessa Arm
    Reporting group description
    		 In Amlessa arm were allocated antihypertensive medication naïve patients, patients on previous antihypertensive monotherapy and patients on previous dual antihypertensive therapy (based on the decision of the Investigator). Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Reporting group title
    Co-Amlessa Arm
    Reporting group description
    		 In Co-Amlessa arm were allocated patients on previous dual antihypertensive therapy (based on the decision of the Investigator) and patients on previous triple antihypertensive therapy. Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Primary: Proportion of patients reaching NBP after 16 weeks of treatment

    		 Close Top of page
    End point title
    		 Proportion of patients reaching NBP after 16 weeks of treatment [1]
    End point description
    Based on the blood pressure measured on visit 5, for each patient was determined if he reached NBP after 16 weeks of treatment with Amlessa or Co-Amlessa. NBP was defined as SBP < 140 mmHg and DBP < 90 mmHg (SBP < 140 mmHg and DBP < 85 mmHg for patients with type 2 diabetes mellitus). This end point display the proportion of all 440 patients in FAS population that has reached NBP after 16 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Each patient was monitored for 16 weeks. Timeframe was the same throughout the whole trial.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The inferential part of statistical analysis was based on two-sided confidence intervals. Two-sided “equal-tails” Clopper-Pearson exact 95%-confidence intervals were calculated to estimate the population proportion of patients meeting a particular target BP or target BP/PWV decrease endpoints. There was no comparison between groups for primary endpoint evaluation. Each treatment arm was evaluated for primary endpoint separately and whole FAS was evaluated for primary efficacy endpoint.
    End point values
    		 Amlessa Arm Co-Amlessa Arm
    Number of subjects analysed
    251
    189
    Units: Proportion of patients
    number (confidence interval 95%)
        Proportion of patients with NBP after 16 weeks
    77.7 (72.0 to 82.7)
    82.5 (76.4 to 87.7)
    No statistical analyses for this end point

    Secondary: Proportion of patients reaching NBP after 4, 8 and 12 weeks of treatment

    		 Close Top of page
    End point title
    		 Proportion of patients reaching NBP after 4, 8 and 12 weeks of treatment
    End point description
    Based on the blood pressure measured on visit 2, visit 3 and visit 4, for each patient was determined if he/she reached NBP after 4, 8 and 12 weeks of treatment with Amlessa or Co-Amlessa. NBP was defined as SBP < 140 mmHg and DBP < 90 mmHg (SBP < 140 mmHg and DBP < 85 mmHg for patients with type 2 diabetes mellitus). This end point displays the proportion of all 440 patients in FAS population that has reached NBP after 4, 8 and 12 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    For secondary endpoint each patient was monitored for 4, 8 and 12 weeks.
    End point values
    		 Amlessa Arm Co-Amlessa Arm
    Number of subjects analysed
    251
    189
    Units: Proportion of patients
    number (confidence interval 95%)
        Proportion of patients with NBP after 4 weeks
    49.4 (43.1 to 55.8)
    36.0 (29.1 to 43.3)
        Proportion of patients with NBP after 8 weeks
    64.5 (58.3 to 70.5)
    63.0 (55.7 to 69.9)
        Proportion of patients with NBP after 12 weeks
    75.3 (69.5 to 80.5)
    81.5 (75.2 to 86.7)
    No statistical analyses for this end point

    Secondary: Mean absolute and relative change from baseline in office SBP and DBP after 4, 8, 12 and 16 weeks of treatment

    		 Close Top of page
    End point title
    		 Mean absolute and relative change from baseline in office SBP and DBP after 4, 8, 12 and 16 weeks of treatment
    End point description
    Based on the blood pressure measured on visits 1-5, for each patient was calculated absolute and relative change from baseline in office SBP and DBP after 4, 8, 12 and 16 weeks of treatment with Amlessa or Co-Amlessa. This endpoint summarizes mean absolute and relative changes from baseline in office SBP and DBP after 4, 8, 12 and 16 weeks of treatment for all 440 patients in FAS population.
    End point type
    Secondary
    End point timeframe
    Each patient was monitored for 16 weeks. Timeframe was the same throughout the whole trial.
    End point values
    		 Amlessa Arm Co-Amlessa Arm
    Number of subjects analysed
    251
    189
    Units: mmHg or %
    arithmetic mean (confidence interval 95%)
        Mean absolute change in SBP after 4 weeks (mmHg)
    -17.4 (-19.1 to -15.6)
    -14.5 (-16.7 to -12.3)
        Mean absolute change in SBP after 8 weeks (mmHg)
    -21.3 (-23.0 to -19.6)
    -21.2 (-23.5 to -18.9)
        Mean absolute change in SBP after 12 weeks (mmHg)
    -23.8 (-25.4 to -22.2)
    -25.8 (-27.9 to -23.8)
        Mean absolute change in SBP after 16 weeks (mmHg)
    -27.1 (-28.6 to -25.5)
    -29.0 (-31.2 to -26.7)
        Mean relative change in SBP after 4 weeks (%)
    -10.8 (-11.9 to -9.8)
    -8.8 (-10.1 to -7.5)
        Mean relative change in SBP after 8 weeks (%)
    -13.4 (-14.4 to -12.3)
    -13.1 (-14.4 to -11.8)
        Mean relative change in SBP after 12 weeks (%)
    -14.9 (-15.9 to -14.0)
    -16.0 (-17.1 to -14.8)
        Mean relative change in SBP after 16 weeks (%)
    -17.0 (-18.0 to -16.1)
    -18.0 (-19.3 to -16.7)
        Mean absolute change in DBP after 4 weeks (mmHg)
    -11.0 (-12.2 to -9.8)
    -8.9 (-10.4 to -7.3)
        Mean absolute change in DBP after 8 weeks (mmHg)
    -13.4 (-14.5 to -12.2)
    -13.3 (-14.8 to -11.7)
        Mean absolute change in DBP after 12 weeks (mmHg)
    -15.2 (-16.3 to -14.1)
    -15.1 (-16.5 to -13.7)
        Mean absolute change in DBP after 16 weeks (mmHg)
    -16.7 (-17.7 to -15.6)
    -16.7 (-18.2 to -15.1)
        Mean relative change in DBP after 4 weeks (%)
    -10.9 (-12.1 to -9.7)
    -8.6 (-10.1 to -7.1)
        Mean relative change in DBP after 8 weeks (%)
    -13.2 (-14.3 to -12.1)
    -13.1 (-14.5 to -11.6)
        Mean relative change in DBP after 12 weeks (%)
    -15.1 (-16.1 to -14.0)
    -14.9 (-16.2 to -13.6)
        Mean relative change in DBP after 16 weeks (%)
    -16.6 (-17.6 to -15.6)
    -16.6 (-18.0 to -15.2)
    No statistical analyses for this end point

    Secondary: Mean absolute and relative changes from baseline to 16 weeks in average 24h SBP and DBP, average awake time SBP and DBP and average sleep time SBP and DBP

    		 Close Top of page
    End point title
    		 Mean absolute and relative changes from baseline to 16 weeks in average 24h SBP and DBP, average awake time SBP and DBP and average sleep time SBP and DBP
    End point description
    Based on the 24h blood pressure measurement at the baseline and at 16 weeks of treatment with Amlessa and Co-Amlessa, for each patient was calculated absolute and relative change after 16 weeks of treatment in 24h SBP and DBP as well as awake time and sleep time SBP and DBP. This end point summarizes mean absolute and relative change after 16 weeks of treatment for all 440 patients in FAS population.
    End point type
    Secondary
    End point timeframe
    Each patient was monitored for 16 weeks. Timeframe was the same throughout the whole trial.
    End point values
    		 Amlessa Arm Co-Amlessa Arm
    Number of subjects analysed
    256
    194
    Units: mmHg or %
    arithmetic mean (confidence interval 95%)
        Mean absolute change in 24h SBP after 16w (mmHg)
    -18.8 (-20.6 to -17.0)
    -23.3 (-25.7 to -20.9)
        Mean relative change in 24h SBP after 16w (%)
    -13.0 (-14.2 to -11.8)
    -15.5 (-16.9 to -14.0)
        Mean absolute change in 24h DBP after 16w (mmHg)
    -12.3 (-13.6 to -11.0)
    -15.2 (-16.7 to -13.7)
        Mean relative change in 24h DBP after 16w (%)
    -12.9 (-14.2 to -11.6)
    -15.9 (-17.4 to -14.4)
        Mean absolute change in awake SBP after 16w (mmHg)
    -19.6 (-21.5 to -17.7)
    -24.7 (-27.2 to -22.1)
        Mean relative change in awake SBP after 16w (%)
    -13.2 (-14.4 to -12.0)
    -16.0 (-17.5 to -14.5)
        Mean absolute change in awake DBP after 16w (mmHg)
    -12.5 (-14.0 to -11.0)
    -16.1 (-17.7 to -14.5)
        Mean relative change in awake DBP after 16w (%)
    -12.7 (-14.0 to -11.3)
    -16.3 (-17.7 to -14.8)
        Mean absolute change in sleep SBP after 16w (mmHg)
    -16.7 (-18.8 to -14.5)
    -19.6 (-22.5 to -16.7)
        Mean relative change in sleep SBP after 16w (%)
    -12.1 (-13.6 to -10.6)
    -13.6 (-15.6 to -11.7)
        Mean absolute change in sleep DBP after 16w (mmHg)
    -11.7 (-13.1 to -10.2)
    -12.8 (-14.7 to -11.0)
        Mean relative change in sleep DBP after 16w (%)
    -13.2 (-14.8 to -11.7)
    -14.3 (-16.4 to -12.2)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Each patient was monitored for 16 weeks. Timeframe for AE reporting was the same throughout the whole trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Co-Amlessa Arm
    Reporting group description
    		 In Co-Amlessa arm were allocated patients on previous dual antihypertensive therapy (based on the decision of the Investigator) and patients on previous triple antihypertensive therapy. Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Reporting group title
    Amlessa Arm
    Reporting group description
    		 In Amlessa arm were allocated antihypertensive medication naïve patients, patients on previous antihypertensive monotherapy and patients on previous dual antihypertensive therapy (based on the decision of the Investigator). Patients were instructed to take one unit of assigned study medication once daily, at about the same time each day (± 3 hours), preferably in the morning and before a meal. Patients were required to take a dose of the medication on the day of the dispensing visit, but not to take the study medication in the morning of any visit following the initial visit.

    Serious adverse events
    		 Co-Amlessa Arm Amlessa Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 265 (0.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Co-Amlessa Arm Amlessa Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 196 (11.73%)
    44 / 265 (16.60%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 196 (2.55%)
    5 / 265 (1.89%)
         occurrences all number
    6
    8
    Blood potassium increased
         subjects affected / exposed
    0 / 196 (0.00%)
    5 / 265 (1.89%)
         occurrences all number
    0
    7
    Blood triglycerides increased
         subjects affected / exposed
    3 / 196 (1.53%)
    5 / 265 (1.89%)
         occurrences all number
    4
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 196 (2.55%)
    4 / 265 (1.51%)
         occurrences all number
    10
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 196 (2.04%)
    3 / 265 (1.13%)
         occurrences all number
    5
    4
    Blood potassium decreased
         subjects affected / exposed
    2 / 196 (1.02%)
    0 / 265 (0.00%)
         occurrences all number
    3
    0
    Blood cholesterol increased
         subjects affected / exposed
    1 / 196 (0.51%)
    2 / 265 (0.75%)
         occurrences all number
    1
    2
    Vascular disorders
    Oedema peripheral
         subjects affected / exposed
    0 / 196 (0.00%)
    4 / 265 (1.51%)
         occurrences all number
    0
    9
    Hypotension
         subjects affected / exposed
    3 / 196 (1.53%)
    2 / 265 (0.75%)
         occurrences all number
    3
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 196 (0.00%)
    2 / 265 (0.75%)
         occurrences all number
    0
    3
    Somnolence
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 265 (0.38%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 196 (1.53%)
    9 / 265 (3.40%)
         occurrences all number
    4
    15
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 196 (0.00%)
    2 / 265 (0.75%)
         occurrences all number
    0
    3
    Infections and infestations
    Viral infection
         subjects affected / exposed
    2 / 196 (1.02%)
    0 / 265 (0.00%)
         occurrences all number
    2
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 09:52:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA